JP5953055B2 - Guide wire - Google Patents

Description

  The present invention relates to a guide wire.

  The guide wire is used for guiding a catheter used for treatment of a site where surgical operation is difficult, treatment for the purpose of minimally invasive to the human body, or examination such as cardiac angiography. For example, when PCI (Percutaneous Coronary Intervention) is performed, the tip of the guide wire protrudes from the tip of the balloon catheter under fluoroscopy, and the coronary artery that is the target site together with the balloon catheter. The tip of the balloon catheter is guided to the vicinity of the blood vessel stenosis.

  As a guide wire used for such treatment, a flexible wire main body (core wire) and a metal cylinder having a contrast property attached to the distal end portion of the wire main body are configured. There is known a guide wire having a single imaging tip having a surface shape of “O” and a coating layer that covers the wire body together with the imaging tip (for example, refer to Patent Document 1).

  The guide wire described in Patent Document 1 can be provided with a curved portion that is curved in a circular arc shape (in one direction) in a natural state in which no external force is applied to the distal end portion of the wire body. In this case, the contrast chip is positioned at the bending portion in a state where the bending portion is inserted. When the guide wire is inserted into a blood vessel that is relatively thin, for example, approximately the same inner diameter as the outer diameter of the guide wire, the guide wire is corrected so that the curved portion is almost linear. End up. In such a state, there is a case where the blood vessel has a side branch branched from the middle thereof, and a guide wire is desired to be inserted into the side branch. In this case, if the distal end portion of the guide wire is directed to the side branch along the bending direction of the bending portion, the insertion operation is likely to be performed.

  However, as described above, since the bending portion at this time is in a straight line state, it is not known under X-ray fluoroscopy which direction the bending portion is bent, and as a result, the distal end portion of the guide wire In practice, it is difficult to make the head face the side branch along the bending direction of the bending portion. For this reason, there has been a problem that the guide wire cannot be inserted into the side branch.

JP-A-7-275367

  The objective of this invention is providing the guide wire which can grasp | ascertain the bending direction of a bending part reliably in a use condition.

Such an object is achieved by the present inventions (1) to ( 4 ) below.
(1) A wire main body that is configured by a long body having flexibility and has a curved portion that is curved in one direction in a natural state without applying an external force to the distal end portion thereof;
A contrast marker provided at or near the curved portion of the wire body and having a high contrast portion and a low contrast portion having different contrast properties;
The contrast marker is installed so that the bending portion is inserted, and is composed of a tubular body that is shorter than the length of the bending portion,
The tubular body has a defect part formed by partially losing the defect part, the defect part is the low contrast part, and the non-defect part other than the defect part is a high contrast part,
The defect portion is a slit that penetrates the tube wall of the tubular body in the thickness direction and is formed along the central axis direction of the tubular body,
One of the high contrast portion and the low contrast portion is directed to the inside of the curve with respect to the curved portion, and the other is directed to the outside of the curve with respect to the curved portion.

(2) The guide wire according to (1), wherein the contrast marker is unevenly distributed on a distal end side of the wire main body on the bending portion.

(3) The guide wire according to (1) or (2), wherein the contrast marker is fixed so that a center line of the tubular body is eccentric with respect to a center line of the bending portion.

(4) A gap is formed between the inner peripheral portion of the contrast marker and the outer peripheral portion of the bending portion so as to be able to be filled with a fixing material for fixing the contrast marker to the bending portion. Thru | or the guide wire in any one of (3).

  According to the present invention, in the contrast marker, one of the high contrast portion and the low contrast portion faces the curved inner side with respect to the curved portion, and the other faces the curved outer side with respect to the curved portion. As a result, the operator of the guide wire can grasp in advance which of the high contrast portion and the low contrast portion is facing the inside of the curve, for example. And even if the guide wire (curved part) is corrected to a linear state by an inserted blood vessel, for example, if the orientation of the contrasted part facing the inside of the curved part is confirmed under contrast, It can be ascertained in which direction the curve is made, that is, the bending direction of the bending portion.

It is a partial longitudinal cross-sectional side view which shows embodiment of the guide wire of this invention. It is the sectional view on the AA line in FIG. It is a fragmentary longitudinal cross-section which shows an example of the use condition of the guide wire shown in FIG.

Hereinafter, the guide wire of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
1 is a partial longitudinal sectional side view showing an embodiment of the guide wire of the present invention, FIG. 2 is a sectional view taken along line AA in FIG. 1, and FIG. 3 is an example of a use state of the guide wire shown in FIG. FIG. In the following, for convenience of explanation, the right side in FIGS. 1 and 3 is referred to as “base end”, and the left side is referred to as “tip”. Further, in FIG. 1, for easy understanding, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated and schematically illustrated. The ratio of is different from the actual.

  In the present embodiment, a guide wire 1 shown in each figure is a guide wire that is used by being inserted into a relatively thin blood vessel (lumen) 100, for example. The guide wire 1 includes a wire body 2 formed of an elongated body, a contrast marker 3 installed at a distal end portion (a portion on the distal end side) of the wire body 2, and a coating that covers the entire wire body 2 together with the contrast marker 3. Layer 4.

  The total length of the guide wire 1 is not particularly limited, but is preferably about 200 to 5000 mm.

  The wire body 2 is made of a single wire having flexibility, that is, having flexibility or elasticity. As shown in FIG. 1, the wire body 2 is provided on a bending portion 21 provided at a distal end portion thereof, a taper portion 22 provided on a proximal end side of the bending portion 21, and a proximal end side of the taper portion 22. And a constant outer diameter portion 23.

The curved portion 21 is a portion that is curved in one direction, that is, curved in an arc shape in a natural state where no external force is applied. The bending portion 21 is a small diameter portion (first constant outer diameter portion) whose outer diameter φd ₃ is the smallest in the wire body 2 and is constant along the wire longitudinal direction. Since the bending portion 21 is provided at the smallest diameter portion in the wire body 2, the bending portion 21 is easily bent (is easily deformed).

The outer diameter constant portion 23 is a large diameter portion (second outer diameter constant portion) whose outer diameter φd ₅ is the largest in the wire main body 2 and is constant along the wire longitudinal direction. A chamfered chamfered portion 231 is provided at the base end of the constant outer diameter portion 23.

The tapered portion 22 positioned between the curved portion 21 and the constant outer diameter portion 23 is an outer diameter gradually decreasing portion in which the outer diameter φd ₄ is gradually decreased in the distal direction. The minimum outer diameter of the tapered portion 22 and the outer diameter φd ₃ of the curved portion 21 are substantially equal, and the maximum outer diameter of the tapered portion 22 and the outer diameter φd ₅ of the constant outer diameter portion 23 are substantially equal. is there.

Further, in the configuration shown in FIG. 1, the taper angle of the taper portion 22 (decrease rate of the outer diameter φd ₄ ) is constant along the wire longitudinal direction, but is not limited to this, for example, along the wire longitudinal direction. There may be sites that change. In this case, for example, a portion where the taper angle is relatively large and the portion where the taper angle is relatively small may be alternately formed a plurality of times.

  By providing the wire main body 2 with the curved portion 21 and the tapered portion 22 which are small diameter portions, the wire main body 2 has a tapered shape as a whole. As a result, the rigidity (bending rigidity, torsional rigidity) of the wire body 2 can be gradually reduced toward the distal end direction. As a result, it is possible to improve the followability to the blood vessel and the safety, and to prevent bending and the like. Further, since the wire body 2 is rich in flexibility at the distal end portion and relatively high in rigidity at the proximal end portion, the flexibility of the distal end portion 11 and excellent operability (pushability, torque) Both transmission and the like).

  The constituent material of the wire body 2 is not particularly limited. For example, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc. Varieties), piano wires, cobalt-based alloys, alloys that exhibit pseudoelasticity (including superelastic alloys), and other metal materials can be used. A superelastic alloy is more preferable.

  The superelastic alloy is relatively flexible, has a resilience, and is difficult to bend. Therefore, by configuring the wire body 2 with the superelastic alloy, the guide wire 1 is particularly formed at the tip side portion. Sufficient flexibility and bendability can be obtained, follow-up to complicatedly bent and bent blood vessels and the like can be improved, and more excellent operability can be obtained, and even if the wire body 2 repeats bending and bending deformation Since the bend crease is not attached due to the resilience provided in the wire body 2, it is possible to prevent the operability from being lowered due to the bend crease attached to the wire body 2 during use of the guide wire 1.

  Superelastic alloys include any shape of the stress-strain curve caused by tension, including those that can significantly measure transformation points such as As, Af, Ms, and Mf, and those that cannot be deformed. However, everything that returns to its original shape by removing stress is included.

  The preferred composition of the superelastic alloy is Ni-Ti alloy such as Ni-Ti alloy of 49-52 atomic% Ni, Cu-Zn alloy of 38.5-41.5 wt% Zn, 1-10 wt% X Cu-Zn-X alloy (X is at least one of Be, Si, Sn, Al, and Ga), 36-38 atomic% Al-Ni-Al alloy, and the like. Of these, the Ni-Ti alloy is particularly preferable. A superelastic alloy typified by a Ni—Ti alloy is also excellent in the adhesion of the coating layer 4.

As shown in FIG. 1, a coating layer 4 is provided on the outer surface of the guide wire 1 so as to cover the entire outer diameter φd ₁ along the wire longitudinal direction. The coating layer 4 can be formed for various purposes. As an example, the coating layer 4 can reduce the friction (sliding resistance) of the guide wire 1 and improve the slidability, thereby improving the operability of the guide wire 1. May improve.

  In order to reduce the friction (sliding resistance) of the guide wire 1, the coating layer 4 is preferably made of a material that can reduce friction as described below. As a result, the frictional resistance (sliding resistance) with the blood vessel wall is reduced, the slidability is improved, and the operability of the guide wire 1 in the blood vessel 100 becomes better. Further, since the sliding resistance of the guide wire 1 is lowered, the guide wire 1 is reliably prevented from being kinked or bent when the guide wire 1 is moved or rotated in the blood vessel 100. Can do.

  Examples of materials that can reduce such friction include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrenes, polycarbonates, silicone resins, fluorine resins ( PTFE, ETFE, etc.) or a composite material thereof.

  The covering layer 4 can also be provided for the purpose of improving safety when the guide wire 1 is inserted into the blood vessel 100 or the like. For this purpose, the covering layer 4 is preferably made of a material having a high flexibility (soft material, elastic material).

  Examples of such flexible materials include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, silicone resin, polyurethane elastomer, polyester elastomer, polyamide. Examples thereof include thermoplastic elastomers such as elastomers, various rubber materials such as latex rubber and silicone rubber, or composite materials in which two or more thereof are combined.

Moreover, the coating layer 4 has a tip 41 and a base end 42 each rounded. Thereby, when the guide wire 1 is pushed into the blood vessel 100 or the like and inserted, it is possible to reliably prevent the blood vessel 100 from being damaged by the distal end 41, or the operator's finger or the like of the guide wire 1 can be held at the proximal end 42. It can be surely prevented from being damaged.
The covering layer 4 may be a single layer or a laminate of two or more layers.

  Moreover, it is preferable that at least the outer surface of the distal end portion 11 of the guide wire 1 is coated with a hydrophilic material. As a result, the hydrophilic material is wetted to produce lubricity, the friction (sliding resistance) of the guide wire 1 is reduced, and the slidability is improved. Therefore, the operability of the guide wire 1 is improved.

  Examples of hydrophilic materials include cellulose-based polymer materials, polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer). Acrylamide polymer substances (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.

  In many cases, such a hydrophilic material exhibits lubricity by wetting (water absorption) and reduces frictional resistance (sliding resistance) with the inner wall of the catheter used together with the guide wire 1. Thereby, the slidability of the guide wire 1 is improved, and the operability of the guide wire 1 in the blood vessel 100 (or in the catheter) becomes better.

  A contrast marker 3 made of a tubular body is installed on the bending portion 21 of the wire body 2. The contrast marker 3 has a curved portion 21 inserted therethrough, and is disposed and fixed at a portion opposite to the tapered portion 22 of the curved portion 21, that is, a portion as close as possible to the tip 211 of the wire body 2. ing. As this fixing method, in this embodiment, a fixing member such as adhesion (adhesive, adhesion with solder or solvent) provided between the inner peripheral portion 35 of the contrast marker 3 and the outer peripheral portion 212 of the bending portion 21. A method of fixing via (not shown) is employed. In addition, as other fixing methods, for example, methods such as fitting, caulking, and fusion (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.) can be used.

  The contrast marker 3 is made of, for example, a metal material such as a noble metal such as gold, platinum, tungsten, or an alloy containing these. Such a metal material is a radiopaque material, and the contrast marker 3 has X-ray contrast properties. Thereby, it can insert in the blood vessel 100, confirming the position of the front-end | tip part 11 (curved part 21) of the guide wire 1 under X-ray fluoroscopy.

  The contrast marker 3 also has a function for grasping the bending direction of the bending portion 21 under X-ray fluoroscopy. As described above, the contrast marker 3 is arranged as close as possible to the tip 211 of the wire body 2, thereby confirming the position of the tip 11 of the guide wire 1 and the bending portion 21 under X-ray fluoroscopy. Both the grasping of the bending direction can be easily and reliably performed at once.

The contrast marker 3 composed of this tubular body has a total length (length) L ₁ shorter than the length L ₂ of the curved portion 21. Thereby, when the bending part 21 deform | transforms, it can prevent that the contrast marker 3 inhibits the deformation | transformation. Further, the outer diameter φd ₆ of the contrast marker 3 is constant along the wire longitudinal direction (the central axis direction of the tubular body).

  As shown in FIGS. 1 and 2, the contrast marker 3 (tubular body) has a slit that penetrates the tube wall in the thickness direction (is missing) and extends in the longitudinal direction of the wire (the central axis direction of the tubular body). (Deficient part) 31 is formed. That is, as shown in FIG. 2, the contrast marker 3 is composed of a member whose cross-sectional shape forms a “C” shape. Such a contrast marker 3 can be divided into a slit 31 and a non-defect portion 32 other than the slit 31. The slit 31 and the non-defect portion 32 have different contrast properties, that is, there is a difference in contrast property. The slit 31 functions as a low contrast portion 33 with low contrast property, and the non-defect portion 32 is contrast-enhanced. It functions as a high-contrast part 34 having high characteristics.

  The contrast marker 3 having the low contrast portion 33 and the high contrast portion 34 is such that the low contrast portion 33 of these contrast portions faces the inside of the curve with respect to the bending portion 21, and the high contrast portion 34 is the bending portion 21. It faces the curved outer side (see FIG. 1). Thereby, the operator of the guide wire 1 can grasp in advance that the low contrast portion 33 is facing the inside of the curve. Even if the guide wire 1 (curved portion 21) is corrected to a straight state by the blood vessel 100 in use (see FIG. 3A), the position and orientation of the low contrast portion 33 are confirmed under fluoroscopy. By doing so, it is possible to reliably grasp in which direction the bending portion 21 is bent, that is, the bending direction of the bending portion 21.

  A case where the guide wire 1 having the above configuration is inserted into the blood vessel 100 and used will be described with reference to FIG. The blood vessel 100 has a side branch 101 that branches off from the middle in the longitudinal direction. Here, a case where the guide wire 1 is inserted into the side branch 101 will be described. This procedure is performed under X-ray contrast.

In the state shown in FIG. 3A, the guide wire 1 is pushed toward the back side (peripheral side) of the blood vessel 100. In this state, since the guide wire 1 is inserted into a relatively thin blood vessel 100 having an inner diameter φd _{2 that} is substantially the same as the outer diameter φd ₁ , the distal end portion 11 (curved portion 21) is almost linear. It has been corrected to the state (straight state).

  The guide wire 1 is further pushed in from the state shown in FIG. At this time, while confirming the orientation of the low contrast portion 33 (slit 31) of the contrast marker 3, that is, as a clue, the direction in which the bending portion 21 is bent is grasped, and the direction is illustrated. Keep it facing down.

  When the distal end portion 11 of the guide wire 1 reaches the side branch 101, the distal end portion 11 is released from the linear state as shown in FIG. At this time, the distal end portion 11 is reliably bent toward the side branch 101 by the restoring force of the bending portion 21, and as a result, the guide wire 1 can be reliably inserted into the side branch 101.

  As mentioned above, although the guide wire of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a guide wire is a thing of arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

  Moreover, although the wire main body is comprised with one wire in the said embodiment, two wires, the 1st wire arrange | positioned at the front end side and the 2nd wire arrange | positioned at the base end side of the 1st wire. These wires may be joined (connected) by welding. In this case, the first wire is preferably made of a superelastic alloy, and the second wire is preferably made of stainless steel.

  Moreover, although the contrast marker is installed in the curved part in the said embodiment, it is not limited to this, For example, you may install in the curved part as much as possible of a taper part.

  In the above-described embodiment, the contrast marker has the low contrast portion facing the inside of the curve with respect to the curved portion and the high contrast portion faces the outside of the curve with respect to the curved portion. May face the inside of the curve with respect to the curved portion, and the low contrast portion may face the outside of the curve with respect to the curved portion.

DESCRIPTION OF SYMBOLS 1 Guide wire 11 Tip part 2 Wire body 21 Bending part 211 Tip 212 Outer peripheral part 22 Taper part 23 Outer diameter fixed part 231 Chamfering part 3 Contrast marker 31 Slit (defect part)
32 Non-defect part 33 Low contrast part 34 High contrast part 35 Inner peripheral part 4 Cover layer 41 Tip 42 Base 100 Blood vessel (lumen)
101 side branch L ₁ , L ₂ length φd ₁ , φd ₃ , φd ₄ , φd ₅ , φd ₆ outer diameter φd ₂ inner diameter

Claims (4)

A wire main body having a bending portion which is configured by a flexible long body and which is bent in one direction in a natural state where no external force is applied to the tip portion;
A contrast marker provided at or near the curved portion of the wire body and having a high contrast portion and a low contrast portion having different contrast properties;
The contrast marker is installed so that the bending portion is inserted, and is composed of a tubular body that is shorter than the length of the bending portion,
The tubular body has a defect part formed by partially losing the defect part, the defect part is the low contrast part, and the non-defect part other than the defect part is a high contrast part,
The defect portion is a slit that penetrates the tube wall of the tubular body in the thickness direction and is formed along the central axis direction of the tubular body,
One of the high contrast portion and the low contrast portion is directed to the inside of the curve with respect to the curved portion, and the other is directed to the outside of the curve with respect to the curved portion. The guidewire according to claim 1, wherein the contrast marker is unevenly distributed on the distal end side of the wire body on the curved portion. The guide wire according to claim 1 or 2, wherein the contrast marker is fixed so that a center line of the tubular body is eccentric with respect to a center line of the curved portion. The gap | interval of the grade which can be filled with the fixing material which fixes the said contrast marker with respect to the said curved part is formed between the inner peripheral part of the said contrast marker, and the outer peripheral part of the said curved part. 4. The guide wire according to any one of 3 above.

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